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By Tove Iren S. Gerhardsen BRUSSELS – Whether research and development into new medicines for poor countries may best be secured through the strengthening of current partnerships or through entirely new schemes was the focus of an expert workshop held in Brussels by the German presidency to the European Union and the European Commission on 2 April.

The workshop focused on the current discussions at the World Health Organization (WHO) Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG,” now being pronounced “iggwigg”), and was meant to provide “EU input to the global debate,” the agenda said. The aim of the workshop was to help the EU and others in their preparation for the IGWG process, sources said.

The EU’s involvement in this work was started under the Finnish EU presidency when the IGWG held its first meeting in December 2006, sources said. One source said the EU believes it can help bridge differences, and a country such as Germany, with both a strong pharmaceutical industry and a strong development focus, knows the issues well.

To PPP or Not to PPP?

Among the speakers at the workshop were representatives of the pharmaceutical industry, WHO, non-governmental organisations, and public-private partnerships (PPPs). A number of sources welcomed the opportunity to hear the concerns of the players and the issues at stake, although some were criticised for not tying their talks enough to the IGWG discussions. Most of the member states left the discussion to the speakers.

The debate centred on pros and cons for PPPs and alternatives such as a prize fund that could finance research and development instead of patents, as well as to what extent intellectual property should be part of the discussion.

Christian Wagner representing NGO Health Action International said that the current IP system does not prompt research and development into tropical diseases and a new scheme is needed. He referred to recent developments in Thailand, the Philippines and India, and said that more countries should join France in supporting developing countries’ use of compulsory licensing, in which that they use exemptions to trade law to allow affordable production of patented products for public health needs.

Wagner said patent pools or prize funds for R&D into medicines for neglected diseases should be considered, and emphasised that access as well as innovation had to be focused on.

Michelle Childs of Knowledge Ecology International (KEI) said that through a prize fund, companies would get their reward for developing medicines in the form of a prize (like an award) from a fund, instead of through high prices safeguarded by patents under today’s system. She said that at a KEI meeting in Geneva on 28 March, an industry representative had said the prize fund idea could be interesting for some diseases that are only found in developing countries and for which there is no R&D. The EU could encourage countries to contribute to such a fund through trade incentives, she said.

Frank Schmiedchen of the German development agency (Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung) also called for a new system, saying that it had been a “major mistake” to shift R&D into medicines from less public to more private. He said intellectual property rights are a major obstacle and trade law flexibilities have to be used to the fullest extent. One industry source said, however, that governments were not interested in funding more R&D as was highlighted in the slow take-off of the Lisbon agenda, aiming to make Europe the most innovative region by 2010.

But the industry disagreed with the idea that the current system is not working. Eric Noehrenberg of the International Federation of Pharmaceutical Manufacturers & Associations said that the current IP model is working and the industry is active in R&D into many neglected diseases, such as HIV/AIDS. He said that the assertion that the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was an “empty promise” was “false.” “We are there and we are active,” he said, but noted that some additional incentives could be used for diseases such as sleeping sickness or dengue fever. Noehrenberg said PPPs should be strengthened and the IP system complemented, such as through advanced purchase schemes, rather than replaced.

Trevor Jones, a professor in the United Kingdom, took a position favourable to industry by saying that prices and patents are rarely linked, but this was contested by many participants. A UK official supported Jones and said the discussion should be focused on R&D and not on prices and patents. Jones said PPPs should be continued and expanded, but with some 70 of them already in existence, some should merge to secure sustainable funding, he said. It was later pointed out that only 15 focus on R&D, and only five have a portfolio, meaning a number of research projects in progress.

Kees de Joncheere of WHO Europe said these diseases could soon affect all populations due to the effect of climate change.

Nicoletta Dentico of the Neglected Diseases initiative (DNDi), a non-profit research organisation, raised questions regarding PPPs, even though DNDi is one. She pointed to issues such as high failure rate and focus on breakthrough innovation, and said that government cannot passively reply on the PPPs only, but should also think of alternatives to boost research into neglected diseases.